Second Alzheimer’s-delaying treatment drug up for FDA approval despite safety concern

Get Our Email Newsletter
The companies, people and issues shaping business in Madison and the Capital Region.

Another experimental Alzheimer’s drug can modestly slow patients’ inevitable worsening by about four to seven months, according to the Associated Press.

Eli Lilly and Co. is seeking FDA approval of a drug called donanemab. If cleared, it would be only the second Alzheimer’s treatment convincingly shown to delay the disease after the recently approved Leqembi from Japanese drugmaker Eisai.

Lilly announced in May that donanemab appeared to work, but today the full results of a study of 1,700 patients were published by the Journal of the American Medical Association and presented at the Alzheimer’s conference.

Both donanemab and Leqembi are lab-made antibodies, administered by IV, that target one Alzheimer’s culprit, sticky amyloid buildup in the brain. Both drugs, however, come with a serious safety concern — brain swelling or bleeding that in the Lilly study was linked to three deaths.

Advertisement

Scientists have long tried and failed to slow Alzheimer’s with amyloid-targeting drugs — and the FDA’s contentious 2021 conditional approval of a drug named Aduhelm soon fizzled amid lack of evidence that it really worked. The approval of Leqembi and promising data for donanemab have reignited interest in attacking amyloid buildup.

Lilly expects results of a late-stage study of a tau-fighting drug next year.

Digital Partners